I. Field of the Invention
The present invention generally relates to a therapeutic composition. More particularly, the present invention relates to a pharmaceutical, nutraceutical, or nutratherapeutical formulation that includes antioxidants. The formulation demonstrates positive effects against cancer, autoimmune disease, viruses and provides antioxidant protection against peroxyl, hydroxyl and super oxide radicals.
II. Description of the Relevant Art
It is well known that free radicals are chemically reactive molecules that damage cellular structure and function. Free radicals are oxidants that damage and destroy healthy cells. Oxygen-based free radicals include peroxyls (ROO—), superoxides (O2—) and hydroxyls (—OH). Sources of free radicals include ultraviolet radiation, carcinogens, and high-fat processed foods. It is also known that physical stress and even normal cell function in the production of energy are both sources for the creation and release of free radicals. A broad variety of disease states have been linked to the presence of free radicals, including arthritis, cancer, heart dysfunction, atherosclerosis, hyperoxia, stroke, cataractogenesis, retinal damage, liver injury, sexual dysfunction, periodontis, vasospasms, dermatitis, and asthma.
In response to the overwhelming presence of oxygen-based free radicals in our natural environment, attention has focused on antioxidants, compounds that can inhibit the cellular damage caused by free radicals. Natural sources of antioxidants are known and include vitamins C and E, broccoli, alpha-Lipoic acid, grapeseed, and green tea extract. While offering an avenue to obtaining the positive effects of antioxidants, the dosages of these natural foods needed to offset the oxidants is extremely high.
Attempts have been made to provide concentrated antioxidants as a pharmaceutical, a nutraceutical, or a nutratherapeutical according to various formulations. Each of these formulations included tetrahydroxy-1,4-quinone (C6H4O6) (hereinafter referred to occasionally as “THQ”) (in its free form and its sulfited form), croconic acid (in its free form and its sulfited form), and catechol as active ingredients. These formulations have gone by various names, including “Entelev®,” “Cantron®” (in three versions), “Cancell®,” and “Protocel®” (in three versions). Perhaps the best known of these early attempts at providing an effective anti-cancer, anti-viral formulation is the “Cantron®” composition which had, in addition to catechol, varied amounts of croconic acid (in its free form and its disulfited form), THQ (in its free form and its sulfited form) and rhodozonic acid, the latter converting in part to croconic acid (in its free form and its disulfited form) during the formulation process. Various additional ingredients to these formulations include copper, potassium, triquinoyl, leuconic acid, and traces of inositol.
While providing some improvement in the state of the art, these formulations have not proven either fully effective or completely desirable. These shortcomings include unmanageable and inadequate dosing requirements, undesirable physical characteristics of the composition, and safety issues related to the manufacturing process.
Dosage management has been a problem with these compositions in that the liquid of known formulations needs to be four to five times per day. This is an extremely difficult schedule to follow even under the best of circumstances. The problem is further compounded by the difficulty of traveling with these compositions which is bulky. The container top is subject to loosening because of the gases naturally generated by the composition.
The physical characteristics of known formulations also make use of these compositions problematic. Specifically, the known compositions are designed to be orally ingested. However, the oral liquid has an extremely foul metallic taste. Users historically found the composition unappetizing, this problem being compounded by the user's need to consume the composition four or five times daily. Beyond taste, the dark black liquid of known compositions is itself visually unappealing. The color of the known compositions is known to stain teeth, clothing, furniture, and carpeting.
Of concern to manufacturers is the production process itself. The manufacturing procedure of the formula is extremely dangerous as the oxidation process to create the various compounds causes the release of a highly toxic and acidic gas. The manufacturing method of known compositions also causes the release of hazardous nitrous peroxides into the atmosphere, causing pollution and possible ozone damage. Experience has taught that the larger the volume of product being produced, the more dangerous the chemical reaction. So dangerous is the manufacturing procedure for known compositions that production on a large scale may lead to injury or death, which is the reason that previous manufacturing has been done on a small scale only. Because of the level of pernicious nitric fumes generated, even protective wear that would ordinarily be effective (such as gas masks) fail to protect the operator. Furthermore, experience has shown that stove wiring, fan motors, vacuum motors and general laboratory equipment must be renewed constantly and at considerable expense due to the presence of these acidic gases. In addition, laboratory cleanliness is all but impossible to maintain given the presence of these gases, resulting in stained walls, floors and furniture. So extreme is the problem that to maintain laboratory cleanliness at even the most rudimentary level the walls must be recoated with paint after the production of each batch. Given these problems, FDA or regulatory authority inspection compliance has been problematic.
Beyond the difficulties associated with the production of known compositions, the known compositions have a variety of demonstrable shortcomings. First, prior compositions fail to produce an optimum effect in that they do not utilize the most effective administration methods or dosages. Second, known compositions are unsafe to manufacture in any significant quantity. Third, known compositions have a black, tarry appearance and are unappealing to the user in appearance. Fourth, known compositions are unappealing to the user in taste.
Accordingly, an improved formulation that demonstrates high antioxidant characteristics, increased efficacy against cancer, autoimmune diseases and a broad array of viruses (including the virus that causes AIDS) while allowing safe manufacture and appeal to the user is desired.